U.S. FDA medical device regulatory submissions are expected to be submitted electronically in accordance with FDA electronic submission policies and technical format requirements. In 2025, FDA updated its structured electronic intake process, and in 2026, this process continues to be applied to ensure submissions are complete, readable, and administratively acceptable before the review clock begins.

Depending on the submission type (e.g., 510(k), De Novo, PMA, IDE) and whether the FDA has implemented an eSTAR template for that pathway, sponsors may be required to submit using eSTAR or an eCopy frameworks.

Failure to meet FDA electronic submission requirements may result in an RTA hold, meaning the FDA will not begin substantive review until the submission is corrected and resubmitted in a compliant electronic format.

eSTAR : Electronic Submission Template and Resource (Estar).

It is a USFDA-developed interactive electronic submission template used for preparing and submitting medical device applications in a standardized format via the CDRH portal.

eCopy / ECR : Electronic Copy Requirement.

The eCopy is the technically compliant electronic package required under the Electronic Copy Requirement (ECR), governed by FD&C Act §745A(b). ECR requirements apply to medical device submissions and define the technical structure and formatting rules for the submission files.

To meet FDA eCopy / ECR requirements, one should ensure the following:

• One complete eCopy/E-STAR per submission (single intake package, single legal manufacturer)
• No partial/staged submissions; replacement Copies must be full replacements
• Signed cover letter required, stating submission type and stage
• PDF rules: searchable, no passwords, no print/copy restrictions, within size limits
• File naming: numeric prefixes (e.g., 001_), no special characters, sequential numbering
• Folder structure: top-level volumes only, no subfolders, FDA naming format required
• Non-PDF files: zipped and placed only in STATISTICAL DATA or MISC FILES (root level only)
• The USFDA will not fix submissions; non-compliance causes a format hold, and review does not start until corrected

For bundled submissions, the FDA expects the following:

• Bundled submissions require one eCopy and one cover letter
• The cover letter must include a clear list/table identifying each submission/device included in the bundle

Overall, in 2026, USFDA electronic submissions are expected to follow both eSTAR requirements (where applicable) and eCopy (ECR) technical format rules. Ensuring compliance with these frameworks supports successful FDA intake and prevents format holds that delay review initiation.

(1) Is ECR a new law in 2026?

No. ECR is based on FD&C Act §745A(b). enforcement clarity is changed in 2026 , not the law itself.

(2) Does using eSTAR mean eCopy rules don’t apply?

No. Technical guideline requirements for documentation remain the same for both

(3) If FDA issues a format hold, can I fix only the error?

No. FDA requires a full replacement eCopy, including:

• New signed cover letter
• Entire corrected submission

Partial corrections are not accepted.

(4) Are password-protected PDFs allowed?

No.

(5) What happens if my PDF is slightly larger than the size limit?

FDA systems will reject it. There is no tolerance for exceeding file size limits.

(6) Can I include multiple legal manufacturers in one eCopy?

No.Each eCopy must correspond to one legal manufacturer

(7) Can eSTAR be used for bundle submissions?

Yes. When eSTAR is applicable:

• eSTAR content may exist for each submission within the bundle
• FDA still expects ONE administrative package (one cover letter, one intake)

eSTAR does not change bundling rules under ECR.